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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Indicator, Physical/Chemical Sterilization Process
510(k) Number K020409
Device Name STEAMPLUS STERILIZATION TEST
Applicant
SPS MEDICAL SUPPLY CORP.
6789 WEST HENRIETTA RD.
RUSH,  NY  14543
Applicant Contact GARY J SOCOLA
Correspondent
SPS MEDICAL SUPPLY CORP.
6789 WEST HENRIETTA RD.
RUSH,  NY  14543
Correspondent Contact GARY J SOCOLA
Regulation Number880.2800
Classification Product Code
JOJ  
Date Received02/07/2002
Decision Date 07/18/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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